Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-24 @ 9:44 PM
NCT ID:
NCT01862432
Brief Summary:
At birth, the passage from intrauterine to the aerial life can be considered as one of the most stressful and painful life events. Skin-to-skin contact (STSC) with mother is known to provide numerous virtues and World Health Organisation (WHO) recently supported the introduction of such care among healthy, term-born neonates. Here, the investigators hypothesized that immediate STSC could reduce neonatal, birth-evoked stress and pain. This randomized controlled trial (RCT) aimed to compare the pain and stress response of C-section born neonates that received either immediate STSC with mother (intervention) or classical support and monitoring (control).
Detailed Description:
Women are recruited before elective c-section.
Randomizatiion is performed just before the operation.
Control group:
The operation is performed as usual, with observation of the newborn by medical staff. The newborn is then wrapped in a blanket and given to the father.
Intervention group:
The newborn is given to the mother in the first minute of life, placed on her chest to allow complete skin-to-skin contact. Observation of the baby is performed in this position. The skin-to-skin contact lasts as long as the operation is not completed or the mother is not able anymore to keep her baby on her chest.
Sampling (in both groups):
* salivary samples are obtained with salivettes from the mother 1)before the operation and 2) after the operation, in the recovery room (90 minutes after birth).
* salivary samples are obtained with salivettes from the newborn 1) 20 minutes after birth and 2) 20 minutes after the vitamin K injection (performed at 60 minutes of life)
* A cord blood sample is obtained for prolactin, ACTH and cortisol analysis.
Video recording:
The newborn is video recorded at the vitamin K injection (from 1 minute before the injection to 5 minutes after) for analysis with the Neonatal Infant Pain Scale.
Satisfaction:
The mother's satisfaction is evaluated with a questionnaire 24 to 48 hours after birth.
Breastfeeding:
The breastfeeding is evaluated by a research nurse 1) at the hospital and 2) by phone interviews, up to 6 months after birth.
Study:
NCT01862432
Study Brief:
Protocol Section:
NCT01862432